FDA.report

ProteX

Primary DI
B686100010
Brand
ProteX
Company
RSI Technology Group, LLC
Model
1
Catalog number
10001
Device description
A sterile, covered, plastic receptacle intended to be used for the collection, preservation, and/or transport of a semen specimen intended for diagnostic and/or therapeutic use including, but not limited to, semen analysis, intrauterine insemination, in vitro fertilization (IVF), and/or intracytoplasmic sperm injection (ICSI). This is a single-use device.
Published
2023-03-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
FMHContainer, Specimen, Sterile

Product Code Classifications

CodeDeviceSpecialtyClass
FMHContainer, Specimen, SterilePathology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B686100010PrimaryHIBCC0

GMDN Terms

TermDefinition
Semen specimen collection containerA sterile, covered, plastic receptacle intended to be used for the collection, preservation, and/or transport of a semen specimen intended for diagnostic and/or therapeutic use including, but not limited to, semen analysis, intrauterine insemination, in vitro fertilization (IVF), and/or intracytoplasmic sperm injection (ICSI). This is a single-use device.

Sterilization Methods

Method
Ethylene Oxide

Contacts

PhoneEmail
8004650368Support@reproductive.solutions

Regulatory Flags

DUNS number
118022050
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
B6861PLSS25SRS0100000ProteX Safe-Seal1600042023-08-23
B686200011ProteX1600022023-08-02
B686600050ProteX with FlightLock Technology1600052026-04-01
B686600061ProteX with FlightLock Technology1600062026-04-01
B6861PC0010SRS010000ProteX11PC0010SRS0100002024-02-01
B6861PLSS01SRS0100000ProteX Safe-Seal1600032023-08-23

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